Status:
COMPLETED
Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion
- Written informed consent
- At least 18 years old
- Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
- No prior systemic first-line therapy for advanced NSCLC
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Able to swallow and retain oral medication
- Adequate organ system function (hematological, hepatic, and renal)
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study
Exclusion
- Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
- Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) \> 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
- Evidence of active bleeding or bleeding diathesis
- Recent hemoptysis
- Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- Use of any prohibited medication
- Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- Ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity except alopecia
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
- Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start
- Recent or concurrent yellow fever vaccination
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00871403
Start Date
July 1 2009
End Date
March 1 2011
Last Update
June 20 2013
Active Locations (2)
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1
GSK Investigational Site
Herlev, Denmark, 2730
2
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT